Hiv
Conditions
Keywords
HIV prevention, HIV testing, PrEP, Implementation Science
Brief summary
The purpose of this study is to assess the effectiveness of the FPI bundled implementation strategy in increasing HIV testing, Pre-exposure prophylaxis (PrEP) linkage (e.g., prescription) and knowledge, and condom use/access.
Interventions
BEHAVIORALFPI
The FPI intervention will be conducted twice per month (across 21 months) in a zip code, and each event will last approximately 4-5 hours. At the event, participants will receive HIV testing, PrEP linkage (e.g., prescription) and knowledge, and condom and use/access.
Sponsors
University of Miami
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This is a stepped wedge trial and all zip codes cross over from pre-assessment period (control) to active intervention. The time/order in which zip codes enter the stepped wedge is the unity of randomization.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Any individual present during the community events at the "five points" (barbershop, hair/beauty salon store or salon, corner store/grocery/neighborhood restaurant, laundromats, car service provider \[e.g. gas station, mechanic, car wash\]) in predominantly Black communities in Miami where HIV prevalence is high. * Pre- and Post-assessment: Individuals are only eligible to complete the survey one time during the Pre-Intervention and during the Post-Intervention phases. * Intervention: Individuals are only eligible to participate in the Intervention phase of this study once every 6 months.
Exclusion criteria
* Individuals who are unable to completely and fully understand the informed (verbal) consent process and the study procedures. * Individuals who have previously completed the survey during the Pre-Intervention and Post-Intervention phases. * Individuals who have participated in the Intervention phase of this study within less than 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in number of residents with recent HIV testing | Up to 23 months | Will be reported as proportion of residents with recent (within 12 months) HIV testing as measured by Five Point Initiative - Community Survey |
| Change in number of residents with PrEP prescription | Up to 23 months | Will be reported as proportion of residents with PrEP prescription as measured by Five Point Initiative - Community Survey |
| Change in PrEP knowledge as measured by Five Point Initiative - Community Survey | Baseline and up to 23 months | Will be reported as the proportion of residents that indicated 'Yes' on the survey. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of residents with recent HIV testing by health organizations | Up to 23 months | Proportion of residents with recent (within 12 months) HIV testing by each of the participating health organizations. |
| Change in condom use as measured by Five Point Initiative - Community Survey | Baseline and up to 23 months | Will be reported as the proportion of residents that indicated 'No' on the survey |
| Number of residents with PrEP prescription by health organizations | Up to 23 months | Number of residents with PrEP prescription by each of the participating health organizations. |
| Change in condom access as measured by Five Point Initiative - Community Survey | Baseline and up to 23 months | Will be reported as the proportion of residents that indicated 'Yes' on the survey |
Countries
United States
Contacts
CONTACTSannisha Dale, PhD
CONTACTSHINE Research Program
PRINCIPAL_INVESTIGATORSannisha Dale, PhD
University of Miami
Outcome results
None listed